Study Summary
This trial is testing a new HIV vaccine to see if it is safe and if it causes an immune response in healthy people who do not have HIV.
Treatment Effectiveness
Study Objectives
11 Primary · 9 Secondary · Reporting Duration: Measured through Month 28
Measured through Month 24
Part A: Frequency of HIV-specific binding Ab responses
Part A: Frequency of adverse events (AEs)
Part A: Frequency of local reactogenicity signs and symptoms
Part A: Frequency of severe adverse events (SAEs)
Part A: Frequency of systemic reactogenicity signs and symptoms
Part A: Magnitude of differential binding to CH505 gp120 compared to CH505 I delta 371 protein
Part A: Magnitude of neutralizing antibody responses
Part A: Magnitude of neutralizing antibody responses against autologous viral isolates
Part A: Monoclonal antibody binding and neutralization response rates
Part A: Response rate of CD4+ T-cell responses
Measured through Month 28
Part B: Frequency of AEs
Part B: Frequency of HIV-specific binding antibody (Ab) responses
Part B: Frequency of SAEs
Part B: Frequency of local reactogenicity signs and symptoms
Part B: Frequency of systemic reactogenicity signs and symptoms
Part B: Magnitude of neutralizing antibody response
Antibodies, Blocking
Part B: Monoclonal antibody binding response rates
Part B: Monoclonal antibody neutralization response rates
Part B: Response rate of CD4+ T-cell responses
Trial Safety
Trial Design
8 Treatment Groups
Part A: Group 2
1 of 8
Part A: Group 1
1 of 8
Part B: Group 5
1 of 8
Part A: Group 3
1 of 8
Part B: Group 6
1 of 8
Part B: Group 7
1 of 8
Part A: Group 4
1 of 8
Part B: Group 8
1 of 8
Experimental Treatment
Non-Treatment Group
107 Total Participants · 8 Treatment Groups
Primary Treatment: CH505w53 · Has Placebo Group · Phase 1
Part A: Group 2Experimental Group · 2 Interventions: CH505TF, GLA-SE adjuvant · Intervention Types: Biological, Biological
Part A: Group 1Experimental Group · 2 Interventions: CH505TF, GLA-SE adjuvant · Intervention Types: Biological, Biological
Part B: Group 5Experimental Group · 4 Interventions: CH505w53, CH505TF, CH505w78, GLA-SE adjuvant · Intervention Types: Biological, Biological, Biological, Biological
Part A: Group 3Experimental Group · 2 Interventions: CH505TF, GLA-SE adjuvant · Intervention Types: Biological, Biological
Part B: Group 6Experimental Group · 4 Interventions: CH505w53, CH505TF, CH505w78, GLA-SE adjuvant · Intervention Types: Biological, Biological, Biological, Biological
Part B: Group 7Experimental Group · 2 Interventions: CH505 M5, GLA-SE adjuvant · Intervention Types: Biological, Biological
Part A: Group 4
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: BiologicalPart B: Group 8
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: BiologicalTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLA-SE adjuvant
2018
Completed Phase 1
~60
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured through month 28
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,153 Previous Clinical Trials
4,770,856 Total Patients Enrolled
James KobieStudy ChairUniversity of Alabama at Birmingham
Magda SobieszczykStudy ChairColumbia University
Eligibility Criteria
Age 18 - 50 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have good general health as shown by medical history, physical exam, and screening laboratory tests.
You are willing to be followed for the planned duration of the study.
You are willing to discuss HIV infection risks and amenable to HIV risk reduction counseling.
References
- Wolfe, Leslie S., James G. Smedley III, Niket Bubna, Althaf Hussain, Richard Harper, and Sigma Mostafa. 2021. “Development of a Platform-based Approach for the Clinical Production of HIV Gp120 Envelope Glycoprotein Vaccine Candidates”. Vaccine. Elsevier BV. doi:10.1016/j.vaccine.2021.05.073.
- 2017. "Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03220724.
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Conditions
Cancer Related
Treatments